Medical Device Components · ISO 9001 / ISO 13485

Quality records that hold up under scrutiny.

QALogger gives small medical device component manufacturers a complete digital quality logbook — inspection records, corrective actions, calibration, supplier quality, and document control. Built for ISO 9001 and ISO 13485 environments.

ISO 13485 aligned Full audit traceability Works offline 8 quality apps $19/month

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Everything a medical device shop needs

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Inspection Log

In-process and final inspection records with full traceability. Timestamped and user-attributed.

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Non-Conformance Reports

Log, investigate, and close out NCRs with root cause analysis and corrective actions linked.

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Supplier Quality Log

Approved vendor list, incoming material quality records, and supplier performance tracking.

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Calibration Log

Equipment calibration schedule and history. Reminders before due dates so nothing slips.

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Document Control

Controlled documents, revision history, approval status, and distribution records.

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Works Offline

Log records anywhere — no Wi-Fi required. All data saves locally on your device.

ISO 9001:2015 clause coverage — out of the box

Clause 10.2Corrective action — CAR Logger
Clause 8.7Nonconforming outputs — NCR Logger
Clause 8.6Release of products — Inspection & Release
Clause 7.1.5Measuring resources — Calibration Logger
Clause 7.2Competence — Training Logger
Clause 8.4External providers — Supplier Evaluation
Clause 9.2Internal audit — Audit Logger
Clause 9.3Management review — Management Review Logger